New stitching tool aims to fix pelvic organ prolapse
NCT ID NCT06805006
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new device called i-Stitch for repairing pelvic organ prolapse in 100 women. The device is used to attach the top of the vagina to a ligament in the pelvis. The goal is to see if it is safe and works well. Researchers will measure symptoms, quality of life, and any complications after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- i-Stitch device
- What this could lead to
- If successful, this device could offer a safe and effective surgical option for repairing pelvic organ prolapse.
- What could go wrong
- This is a small, early-stage study with only 100 participants. The device may not work better than existing methods, and surgery carries risks like infection or complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with symptomatic pelvic organ prolapse indicated for a surgical intervention.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Surgery for POP * SSLF with usage of i-Stitch device (\& i-Stitch Loading Units) * Concomitant procedures are allowed * Women minimum 18 years old * Written informed consent for surgery Exclusion Criteria: * infection (active or latent) * allergies to the materials used * benign or malignant changes * anticoagulation disorders * autoimmune connective tissue disorders * any uterus pathologies
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Isar Kliniken GmbH
Munich, Bavaria, 80331, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can strength training steady the walk and strengthen the pelvic floor after menopause?
- Can a biological mesh improve pelvic floor surgery?
- Can targeted exercises ease mild pelvic organ prolapse without surgery?
- AI may predict which pelvic floor therapy works best
- Can a small pressure drop make prolapse surgery less painful?
- Could a simple surgical step make hysterectomies safer?